LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Head and Neck Neoplasms

Treatments: Drug: Afatinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345669

2011-000392-14 (EudraCT Number)

1200.131

Details and patient eligibility

About

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Enrollment: 617 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
2. Unresected tumour prior to chemo-radiotherapy (CRT)
3. Concomitant CRT completed prior to randomisation
4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria

1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
4. Known pre-existing Interstitial Lung Disease (ILD)
5. Pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

617 participants in 2 patient groups, including a placebo group

Afatinib (BIBW 2992)

Experimental group

Description:

Once daily

Treatment:

Drug: Afatinib

Placebo

Placebo Comparator group

Description:

Once daily

Treatment:

Drug: Placebo